Wound closure system

ABSTRACT

A wound closure system and a method of reducing the size of an open wound are disclosed. A suture line is sutured through body tissue adjacent an open wound, the suture line sutured so as to pass into the body tissue at an entry point and exit at an exit point, the suture line including a plurality of barbs extending outwardly at an acute angle with respect to a surface of the suture line. A biasing member applies a continuous pulling force on the suture line for stretching the body tissue toward the open wound, wherein the biasing member is configured to take up any slack of the suture line during stretching of the body tissue and keep the suture line taut.

TECHNICAL FIELD

The principles disclosed herein relate generally to wound closure byfacilitating stretching of body tissue. More specifically, thedisclosure relates to a system and method of facilitating stretching thebody tissue adjacent a wound by use of continuous or dynamic force.

BACKGROUND

Surgical procedures such as tumor removal or fasciotomies can result inlarge skin wounds. Chronic wounds such as diabetic ulcers frequently donot heal. Techniques have been developed to facilitate the wound closureof large skin defects and chronic wounds.

Common methods for closure of wounds and skin defects include splitthickness skin grafting, flap closure and gradual closure utilizingtissue expansion. A split thickness skin graft involves removing apartial layer of skin from a donor site, usually an upper leg or thigh,and leaving the dermis at the donor site to re-epithelialize. In thismanner, a viable skin repair patch can be transferred or grafted tocover the wound area. The graft is often meshed, (which involves cuttingthe skin in a series of rows of offset longitudinal interdigitatingcuts) allowing the graft to stretch to cover an area two or three timesgreater than the wound, as well as provide wound drainage while healing.Normal biological function of the skin heals the cuts after the grafthas been accepted. A meshed graft of this type requires a smaller donorarea than a conventional non-meshed or full thickness skin graft. Flapclosure involves transferring skin from an adjacent region to the wound.This technique is only effective in anatomical regions that are amenableto transfer of adjacent skin. It is also a more complex surgicalprocedure involving increased surgical costs and risks. Both of thesemethods do not provide optimal cosmesis or quality of skin cover. Otherdisadvantages of these methods include pain at the donor site, creationof an additional disfiguring wound, and complications associated withincomplete “take” of the graft. In addition, skin grafting oftenrequires immobilization of the limb, which increases the likelihood ofcontractures. The additional operation and prolongation of hospital stayis an additional economic burden.

Gradual, or progressive, closure is another method of wound closure.This technique may involve suturing vessel loops to the wound edge anddrawing them together with large sutures in a fashion similar to lacinga shoe. In addition, the wound edges may be progressively approximatedwith suture or sterile paper tape. The advantages of this gradual, orprogressive, technique are numerous: no donor site is required forharvest of a graft; limb mobility is maintained; superior cosmeticresult, more durable skin coverage, better protection because skin isfull thickness, and maintenance of normal skin sensation may all beachieved.

Existing devices for effecting a gradual closure, however, have manydisadvantages. Current methods and devices rely on static or elasticribbon or suture material which must be repeatedly readjusted in orderto draw wound edges together because a relatively small skin movementsubstantially eliminates much of the closure force. Even with constantreadjustment, maintenance of near constant tension over time isdifficult, if not impossible, to achieve. Since widely used existingclosure techniques involve use of relatively inelastic materials such assutures or surgical tape, a substantial amount of tension is put on thewound edges during periodic adjustment to obtain the necessary closureforce. Excessive tension may cut the skin or cause necrosis due to pointloading of the tissue.

What is needed in the art is a gradual wound closure technique that isself-regulating and self-adjusting and uses continuous or dynamictension to draw the wound edges together, without the need for constantreadjustment involved with the static systems.

SUMMARY

The principles disclosed herein relate to wound closure by facilitatingstretching of body tissue. The disclosure relates to a system and methodof facilitating stretching/expanding the body tissue adjacent a wound byuse of dynamic or continuous force.

According to the present disclosure, the term “body tissue” may refer tohuman or animal tissue and may include internal and external tissue suchas skin tissue (the epidermis and the dermis), subcutaneous tissue (thehypodermis), fascia tissue, organ tissue, etc.

The disclosure is directed to a wound closure system includingcomponents adapted to apply a dynamic or continuous tension force on asuture line that is sutured to body tissue surrounding a wound. Thedynamic tension force draws the suture line toward the wound closuresystem facilitating stretching of the body tissue over the wound area.

In one particular aspect, the disclosure is directed to a wound closuresystem comprising a biasing member that applies a dynamic or continuousforce to a suture line that is sutured to body tissue surrounding awound, wherein the suture line includes a plurality of barbs configuredto grab the body tissue. According to one embodiment, the barbed sutureline extends around substantially the entire periphery of the wound andapplication of tension to the suture line draws and stretches the bodytissue toward the wound. According to another embodiment, the sutureline can also be sutured to the body tissue surrounding the wound in amanner so as to extend across the wound, i.e., in a “shoe-lace”configuration in use of the wound closure system.

In another particular aspect, the biasing member that provides tensionon the barbed suture line may be included as part of a separatetensioning apparatus that may be fixedly attached near the vicinity ofthe wound area. In other embodiments, the tensioning apparatus may beattached further away from the wound area, with the dynamic tensionforce being directed to the wound area.

In another particular aspect, instead of including a separate tensioningapparatus, the wound closure system may utilize a line that is connectedto the barbed suture line or the barbed suture line itself that includeselastic material to provide the dynamic tension on the body tissuesurrounding the wound. Also, an elastic line or elastic suture line canbe used in combination with a separate tensioning apparatus.

In yet another particular aspect, the disclosure is directed to a methodof closing a wound, the method comprising the steps of suturing a barbedsuture line to body tissue surrounding a wound and applying a dynamic orcontinuous tension force on the suture line to draw and stretch the bodytissue toward the wound.

In yet another particular aspect, the disclosure is directed to a woundclosure kit comprising a barbed suture line for attachment to bodytissue surrounding a wound and a biasing member adapted to providecontinuous or dynamic tension on the line for stretching body tissue.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of the description, illustrate several aspects of the disclosureand together with the detailed description, serve to explain theprinciples of the disclosure. A brief description of the drawings is asfollows:

FIG. 1 is a perspective view of a wound closure system in accordancewith the principles of the present disclosure;

FIG. 2 illustrates the wound closure system of FIG. 1 in operationadjacent a wound area;

FIG. 2A illustrates the wound closure system of FIG. 1 in operation inan alternative arrangement adjacent the wound area;

FIG. 3 is an exploded perspective view of a tensioning apparatus of thewound closure system of FIG. 1;

FIG. 4 is a cross-sectional view of the tensioning apparatus of FIG. 3taken along a line 4-4 of FIG. 3, illustrating a knob of the tensioningapparatus in a fully extended position;

FIG. 5 is a cross-sectional view similar to the view of FIG. 4,illustrating the knob of the tensioning apparatus in a fully depressedposition;

FIG. 6 is a side elevation view of a spool of the tensioning apparatusof FIG. 3;

FIG. 7 is a top plan view of the spool of FIG. 6;

FIG. 8 is a bottom plan view of the spool of FIG. 6;

FIG. 9 is a cross-sectional view taken along line 9-9 of FIG. 7;

FIG. 10 is a cross-sectional view taken along line 10-10 of FIG. 8;

FIG. 11 is a top perspective view of a base of the tensioning apparatusof FIG. 3;

FIG. 12 is a bottom perspective view of the base of FIG. 11;

FIG. 13 is a top plan view of the base of FIG. 11;

FIG. 14 is a bottom plan view of the base of FIG. 11;

FIG. 15 is a side elevation view of the base of FIG. 11;

FIG. 16 is a cross-sectional view taken along line 16-16 of FIG. 13;

FIG. 17 is a top perspective view of a biasing member of the tensioningapparatus of FIG. 3;

FIG. 18 is a top plan view of the biasing member of FIG. 17;

FIG. 19 is a side elevation view of the biasing member of FIG. 17;

FIG. 20 is a top perspective view of a knob of the tensioning apparatusof FIG. 3;

FIG. 21 is a bottom perspective view of the knob of FIG. 20;

FIG. 22 is a top plan view of the knob of FIG. 20;

FIG. 23 is a bottom plan view of the knob of FIG. 20;

FIG. 24 is a cross-sectional view taken along line 24-24 of FIG. 22;

FIG. 25 is a top perspective view of a cover of the tensioning apparatusof FIG. 3;

FIG. 26 is a bottom perspective view of the cover of FIG. 25;

FIG. 27 is a top plan view of the cover of FIG. 25;

FIG. 28 is a bottom plan view of the cover of FIG. 25;

FIG. 29 is a cross-sectional view taken along line 29-29 of FIG. 28;

FIG. 30 is a front elevation view of the cover of FIG. 25;

FIG. 31 is a top perspective view of a lock button of the tensioningapparatus of FIG. 3;

FIG. 32 is a bottom perspective view of the lock button of FIG. 31;

FIG. 33 is a rear elevation view of the lock button of FIG. 31;

FIG. 34 is a bottom plan view of the lock button of FIG. 31;

FIG. 35 is a cross-sectional view taken along line 35-35 of FIG. 34;

FIG. 36 is a side elevation view of a dowel pin configured to be placedbetween the knob and the spool of the tensioning apparatus of FIG. 3;

FIG. 37 is a side elevation view of a linear spring configured to beplaced around the dowel pin of FIG. 36 between the knob and the spool ofthe tensioning apparatus of FIG. 3;

FIG. 38 is a top perspective view of a body anchor suitable foranchoring the tensioning apparatus of FIG. 3 to body tissue around awound;

FIG. 39 is a top perspective view of another embodiment of a body anchorsuitable for anchoring the tensioning apparatus of FIG. 3 to body tissuearound a wound; and

FIGS. 40-42 illustrate one exemplary method of attachment for attachinga barbed suture of the wound closure system of FIGS. 1-2 to a tensionline wrapped around the spool of the tensioning apparatus of FIG. 3.

DETAILED DESCRIPTION

The inventive aspects of the disclosure will now be described byreference to the several drawing figures.

A. Wound Closure System

FIGS. 1 and 2 illustrate one embodiment of a wound closure system 10having features that are examples of inventive aspects disclosed herein.The wound closure system 10 includes a suture line 12 having a pluralityof barbs 13 distributed around the circumference of the suture line 12.The barbed suture line 12 is configured to be sutured to body tissuesurrounding a wound 14, as shown in FIG. 2. The barbed suture line 12may include needles 16 at the ends thereof to facilitate suturing theline 12 to body tissue. As shown in FIG. 2, once the line 12 has beensutured around the wound area 14, the needles 16 may be removed and theends tied together to form a closed loop around the wound area 14.

The wound closure system 10 illustrated in FIGS. 1 and 2 includes atensioning apparatus 18 configured to apply dynamic or continuoustension to the barbed suture line 12 after the line 12 has been suturedinto body tissue surrounding the wound 14. When tension is applied tothe barbed suture 12, the body tissue is stretched toward or over thewound area 14 to decrease the size of the open wound area 14.

According to one embodiment of the suture line of the wound closuresystem 18, the barbs 13 of the suture line 12 may be unidirectional suchthat all of the barbs 13 extend out at an acute angle along the samedirection with respect to the longitudinal axis of the suture line 12.

As will be discussed in further detail below, it is also contemplatedthat the suture line 12 could be provided with two sections of barbs 13,wherein all the barbs 13 in the first section extend out at an acuteangle in a first direction and all the barbs 13 in the second sectionextend out at an acute angle in a second opposite direction. Such suturelines can be used, for example, when body tissue on opposing sides of awound 14 are sutured starting from the same point going to the oppositeend of the wound 14. As shown in FIG. 1, if the depicted barbed sutureline 12 extending out of the tensioning apparatus 18 was a single line,then the line might include such a two-section barb distribution.However, the embodiment shown in FIG. 1 could be an example thatincludes two separate suture lines 12 that are attached to a spoolstructure 20 within the tensioning apparatus 18 and wound separatelywithin the tensioning apparatus 18 as will be discussed in furtherdetail below.

The barbs 13 of the barbed suture 12 may be flexible such that, whensuturing, they elastically flex inwardly toward the line surface tofacilitate passing through body tissue. When a barb 13 passes throughthe body tissue and comes out the other side of the body tissue, thebarb 13 flexes again outwardly from the suture line surface to provide acatch and grabs the body tissue if the suture 12 is pulled in theopposite direction. In this manner, the barbed suture 12 can be suturedthrough the body tissue as in a conventional suture, however, preventingany back-up of the suture once passed through body tissue.

It should be noted that the wound closure system 10 can be used to applya tension force on the suture line 12 in either direction with respectto the barbs 13. For example, if the tension is applied with thedirection of the barbs 13, the barbed suture 12 operates in a similarmanner to a conventional suture and slides through the body tissue topull the sides of the body tissue toward or over the open wound area 14.However, as noted above, the barbs 13 still play a role during theinitial suturing of the body tissue by preventing back-up of the sutureline 12. If the wound closure system 10 is used such that tension isapplied against the direction of the barbs 13, the body tissue isstretched toward or over the open wound area 14 by the grabbing actionof the barbs 13.

According to one embodiment, the tensioning apparatus 18 of the woundclosure system 10 may also include a separate line 22 that is woundwithin the tensioning apparatus 18 and that is adapted to be attached tothe barbed suture line 12. This line 22 may be referred to as a tensionline 22 within the present disclosure. One example method of attachingthe barbed suture line 12 to a tension line 22 that is already woundwithin the tensioning apparatus 18 is shown in FIGS. 40-42. As shown inFIGS. 40-42, according to one embodiment, the barbed suture line 12 mayinclude a crimp structure 24 at one of the ends of the barbed sutureline 12. The end that includes the crimp structure 24 could be the endwith the needle 16 or the opposite end. The crimp structure 24 isinserted into a receiver structure 26 attached to one of the ends of thetension line 22 that is wound within the tensioning apparatus 18.Further details of such an attachment system will be discussed below.Other methods of attachment, including tying a knot between the barbedsuture line 12 and the tension line 22, may be used in attaching thebarbed suture line 12 to a separate tension line 22 wrapped around thespool 20 of the tensioning apparatus 18 of FIGS. 3-5.

Although the embodiment of the wound closure system 10 illustrated inFIGS. 1-2 is depicted as including a separate tensioning apparatus 18,the wound closure system may instead simply utilize an elastic line thatis connected to the barbed suture line 12. In other embodiments, thebarbed suture line 12 may include elastic properties and may be used asthe elastic line itself that provides a biasing force to apply thedynamic tension on the body tissue surrounding the wound 14. An elasticline or elastic suture line can also be used in combination with aseparate tensioning apparatus such as the tensioning apparatus 18 shownin FIGS. 1-5.

With the use of a separate tensioning apparatus 18, an inelastic line 22connected to a barbed suture line 12 or simply an inelastic barbedsuture line 12 can be utilized to draw the body tissue toward the wound14 since the tensioning apparatus 18 provides the biasing mechanismadapted to provide the dynamic or continuous force needed for woundclosure.

According to one embodiment, tensioning apparatus 18 includes a biasingmember 30 (shown in FIGS. 3 and 17-19) mounted within the tensioningapparatus 18 to provide the dynamic or continuous tension force onbarbed suture line 12. As the body tissue stretches and grows over thewound 14, the body tissue moves toward the wound area, reducing the sizeof the open wound area 14 and at the same time reducing the tension onthe barbed suture line 12, creating “slack” on the line 12. Biasingmember 30 provides tension to take up this slack on the line 12.Although depicted as a coiled spring in FIGS. 3 and 17-19, the biasingmember 30 may include other structures. The biasing member 30 may be aconstant-force spring designed to provide a constant level of tension onthe line 12, 22 when it is in a loaded state. The biasing member 30 mayalternatively be a nonconstant-force spring designed to provide varyingamounts of force on the line 12, 22 depending upon how tightly it iswound. As one skilled in the art will appreciate, the force applicationcharacteristics of such springs depend upon factors such as themechanical properties of the springs.

In certain embodiments, the tension force that is applied to the barbedsuture 12 is usually at least 1 oz. and usually no greater thansixty-four oz., commonly between thirty and fifty oz.

If a separate tensioning apparatus 18 is used in the wound closuresystem, that tensioning apparatus 18 may be secured to a patient bymechanical attachment means such as by adhesives, by suturing, or byother methods as will be discussed in further detail below. Thetensioning apparatus 18 can be located proximate to the wound area 14 ormay be provided at a distant location remote from the patient's body,with the tension force still being directed to the wound area 14.

Depending upon the arrangement of the wound closure system (e.g., withthe use of multiple tensioning apparatuses) and the barbed suture linewith respect to the wound, the wound closure system 10 can be used toclose virtually any sized wound.

B. Tensioning Apparatus

Referring to FIG. 3, an exploded perspective view of the tensioningapparatus 18 of the wound closure system 10 is illustrated therein. Thetensioning apparatus 18 of the present disclosure is similar instructure and operation to the tensioning apparatus described incommonly owned U.S. Pat. No. 7,455,681, the entire disclosure of whichis hereby incorporated by reference. The tensioning apparatus 18includes a base 40, a cover 50, a spool 20 that seats on the base 40,the biasing member 30 that is placed around the spool 20, a knob 60 usedto wind the biasing member 30 for application of tension, and a linearspring 70 that is placed around a dowel pin 80 that is positionedbetween the knob 60 and the spool 20. As will be discussed in furtherdetail below, the linear spring 70 provides a biasing force upwardly andallows the knob 60 to be pushed down with respect to the cover 50 todisengage the knob 60 from the cover 50 so that the knob 60 can beturned in a counterclockwise direction to let the line 12 to come out.This may be advantageous during initial set-up or during system removalfrom the wound area 14. The operation of the linear spring 70, as wellas the interaction between the knob 60 and the cover 50 are illustratedin FIGS. 4 and 5.

Referring now to FIGS. 6-10, there is generally illustrated the spool 20of the tensioning apparatus 18. The spool 20 includes an upper springmount portion 21, a lower line mount portion 23, and a main plate 25separating the two portions. In this embodiment, all the portions of thespool 20 are depicted as integrally formed from one unitary piece.However, it will be appreciated that in other embodiments, the spool maybe formed from multiple separate pieces that are coupled together.

The upper spring mount portion 21 has a generally cylindrical shape. Theupper mount portion 21 includes a slot 27 adapted to receive one end ofthe biasing member 30 as will be discussed in further detail below. Theupper spring mount portion 21 also includes a well 19 for the placementof the linear spring 70 (see FIGS. 4, 5, and 37). The well 19 is not athroughhole and includes a closed end in the upper spring mount portion21. When the linear spring 70 is placed within the well 19, a portion ofthe spring 70 may protrude upwardly out of the well 19.

The lower tension line mount portion 23 defines two winding grooves 9,11. The lower winding groove 9 is defined between two seat plates, alower seat plate 1 and an upper seat plate 3. The upper winding groove11 is defined between the main plate 25 and the upper seat plate 3. Theseat plates 1, 3 provide structure for seating the spool 20 into thebase 40 of the tensioning apparatus 18. The spool 20 also defines anupper opening 5 going through the upper seat plate 3 and a lower opening7 going through the lower seat plate 1. The openings 5, 7 in the platesare aligned to define a large opening going through the plates 1, 3. Theopenings 5, 7 in the seat plates allow a line or lines 12, 22 to bedirected between the upper winding groove 11 and the lower windinggroove 9 of the spool 20.

The openings 5, 7 can be used such that when a line 12, 22 is insertedthrough one of the openings 5, 7, a knot may be tied or a crimp tubeapplied, the knot or the dimension of the crimp tube being large enoughthat the tied or crimped end of the line 12, 22 will not slip throughthe opening. Another line or the other end of the same line can beinserted through the opening located in the other seat plate, with asimilar knot tied or crimp tube applied. In this manner, a single lineor multiple lines 12, 22 can be coupled to the spool 20 ready to bewound. If a single line is used, the two ends of the line are preferablyattached to openings in separate seat plates 1, 3 to facilitate windingof the line 12, 22 and keep line 12, 22 untangled during winding. Itwill be appreciated that there are numerous methods for attaching one ormore lines to the spool 20 using the winding grooves 9, 11 and theopenings 5, 7 provided in the seat plates 1, 3 of the spool 20.

Referring now to FIGS. 11-16, there is generally illustrated the base 40of the tensioning apparatus 18. Base 40 includes a generally circularmain body portion 41 and an elongated snout portion 42. Disposed aroundthe main body 41 are fastener mounting openings, generally indicated at43 that may be used to mount the base 40 to cover 50 with fasteners.

The base 40 defines a circumferential wall portion 44 protrudingupwardly therefrom. The wall portion 44 defines an exterior wall portion45 and an interior wall portion 46. The interior wall portion 46 definesan interior cavity 47 shaped to receive the lower tension line mountportion 23 of the spool 20. The wall portion 44 of the base 40 alsodefines a slot 48 for directing the line 22 outside of the tensioningapparatus 18 and toward the wound 14. Once the line 22 exits thetensioning apparatus 18, the line 22 may be connected to the barbedsuture 12, as noted above.

The snout portion 42 of the base 40 is provided with an elongate shapethat matches the contour of the cover 50 of the wound closure system 10for directing the line 22 out of the tensioning apparatus.

Referring now to FIG. 17-19, there is generally illustrated therein thebiasing member 30 of the tensioning apparatus 18. The biasing member 30is depicted as a spring formed from a coiled-up band 31. According toone embodiment, the coiled-up band 31 may be formed from a metal. Othermaterials are suitable. As discussed previously, the spring 31 can be aconstant force spring that provides a constant level of tensionregardless of how tight it is wound or it can be a nonconstant-forcespring that provides different levels of tension at different degrees oftightening. According to one embodiment, the band 31 is made of type 301high-yield stainless steel. In certain embodiments, the biasing member30 can provide a load force of about four lbs. As will be appreciated inthe art, the load force of the biasing member 30 can vary depending oncertain properties such as the thickness, the diameter, or the materialof the band 31.

The band 31 defines an inner end 32 and an outer tab portion 33. Thecoiled up band 31 is positioned around the upper spring mount portion 21of the spool 20. When positioned as such, the inner end 32 of the band31 is placed within the slot 27 defined on the upper spring mount 21 ofthe spool 20. The outer tab 33 of the band 31 cooperates with the knob60 of the tensioning apparatus 18 for winding purposes. Winding of thebiasing member 30 will be described in detail further below.

Referring to FIGS. 20-24, there is generally illustrated the knob 60 ofthe tensioning apparatus 18 that is used to load and unload the biasingmember 30. The knob 60 includes a generally cylindrical body 61 with anexterior surface 62 and an interior cavity 63 defined by an interiorsurface 64. The interior cavity 63 is shaped and sized to tightlyreceive the biasing member 30. The interior surface 64 includes radiallyarranged vertical indents 65 that cooperate with the outer tab 33 of thebiasing member 30 to wind the biasing member. The interior surface alsoincludes a slot 67 adapted to receive a portion of the dowel pin 80(seen in FIGS. 4, 5, and 36). As noted previously, the dowel pin 80 isconfigured to receive the linear spring 70 that is positioned betweenthe knob 60 and the spool 20 and biases the knob 60 upwardly when it ispushed down with respect to the cover 50. See FIGS. 4, 5, 36, and 37.

Still referring to FIGS. 20-24, the exterior surface 62 of the knob 60defines radially arranged gripping features 66 to facilitate turning theknob during winding. The gripping features 66 are depicted as generallyvertical grooves but may be other structures adapted to facilitate thewinding process of the biasing member 30.

The exterior surface 62 of the knob 60 also includes a flange 68 withhorizontal tabs 69 arranged radially around the circumference of theknob 60. The tabs 69 include ramped surfaces 71 that ramp upwardly in acounterclockwise direction. The tabs 69 define square faces 72 at theend of the ramped surfaces 71. The tabs 69 are spaced and define gaps 73thereinbetween. The tabs 69 cooperate with the cover 50 of thetensioning apparatus 18 to wind the biasing member 30, to lock thebiasing member 30 when it is loaded, and to release the biasing member30 when desired, as will be described below in further detail.

Referring now to FIGS. 25-30, there is generally illustrated therein thecover 50 of the tensioning apparatus 18. The cover 50 generally includesan interior shape configured to fit on exterior of the base 40. Thecover includes a main body portion 51 and an elongate snout portion 52.The main body portion 51 fits over the main body portion 41 of the base40 and the snout portion 52 fits over the snout portion 42 of the base40. The cover 50 includes an inner wall 53 that is shaped and sized tosnugly fit over the wall portion 44 of the base 40.

Adjacent the rear side, the cover 50 defines holes 54 for suturing thetensioning apparatus 18 to body tissue. As noted previously, althoughdepicted as being adapted for mounting to the body by way of suturing,the cover 50 need not have the suture holes 54 and the tensioningapparatus 18 can be secured to the patient by other methods such as byadhesive, by adhesive tape, by a bandage, by straps, by a wounddressing, etc. As also discussed previously, the tensioning apparatus 18can also be located at a location outside the patients body if desired,distal to the wound area 14.

The elongate snout portion 52 of the cover 50 defines a pair of channels55 for guiding the tension line 22 or the barbed suture line 12 towardthe wound 14. Either the tension line 22 or the barbed suture line 12coming out of the tensioning apparatus 18 can, thus, be in line with therest of the barbed suture line sutured to body tissue around theperiphery of the wound 14, as seen in FIG. 2. In this manner, an evendistribution of pulling force can be kept on the body tissue aroundwound 14. Depending on the shape of the wound 14, the snout portion 52of the cover 50 can be placed at various positions depending on wherethe force is desired to be concentrated. By providing structural supportfor the line 12, 22, the snout portion 52 can also allow the tensioningapparatus 18 to be positioned at a remote location from the wound 14.Remote placement of the tensioning apparatus 18 makes it easier toinspect and dress the wound 14.

The elongate snout portion 52 of the cover 50 can also be used toprovide an alternative method of securing the tensioning apparatus tothe patient's body. As shown in FIGS. 25, 27, 29, and 30, the front ofthe snout 52 includes a ramped surface 56. The ramped surface 56 isconfigured to cooperate with a body anchor 100 (see FIG. 38) that isattached to the body of a patient adjacent the wound 14 as described inU.S. Pat. No. 7,455,681, the entire disclosure of which has beenincorporated herein by reference. Please see FIG. 39 for anotherembodiment of a body anchor 200 suitable for use with the tensioningapparatus 18. As described in U.S. Pat. No. 7,455,681, the tension linetab 101 of an anchor 100 can be used to fixedly mount the cover 50 tothe anchor 100. The ramped surface 56 is inserted within the tensionline slot 102 defined by the tension line tab 101 of the anchor 100 asthe tension line tab 100 abuts against the front of the snout 52. Withthis feature, the cover 50 can be mounted onto an anchor 100 adjacentthe wound 14 and the tensioning apparatus 18 can be allowed to move withthe anchor 100 as the body tissue is stretched toward the wound 14.Please refer to FIG. 2 for this type of an attachment method used forthe tensioning apparatus 18.

As illustrated in the bottom view of the base 40 in FIG. 12, the bottomside of the base 40 may include an indentation 57 configured toaccommodate the thickness of a staple that may be mounted on an anchor100 for securing the anchor 100 on the body.

As seen in the bottom perspective view of the cover 50 in FIG. 26 and inthe bottom plan view of the cover 50 in FIG. 28, the inner wall 53 ofthe cover 50 defines a flange 58 surrounding the inner perimeter of themain body portion 51. The flange 58 is adapted to trap the flange 68 ofthe knob 60 to capture the knob 60 in between the base 40 and the cover50 of the tensioning apparatus 18. The flange 58 of the cover 50 definesramped tabs 59 located around the periphery thereof that are adapted toslide over the ramped surfaces 71 of the horizontal tabs 69 of the knob60 and fit into the rectangular gaps 73 defined between the horizontaltabs 69 as the knob 60 is turned clockwise, as will be described infurther detail below. Although the cover 50 is shown as being coupled tothe base 40 by fasteners, it may be coupled to the base 40 by variousother methods including friction fit, by adhesives, by a snap fit, etc.

The cover 50 may also include a cutout 91 at the rear for accommodatinga locking button 90 that can be used to lock the knob 60 with respect tothe cover 50 and prevent relative rotation thereinbetween, as will bediscussed in further detail below.

Referring now to FIGS. 31-35, the locking button 90 of the tensioningapparatus 18 is illustrated. The locking button 90 can be used to lockthe knob 60 with respect to the rest of the tensioning apparatus 18 toprevent any unwanted rotation of the knob 60. The locking button 90 isseated within the cutout 91 of the cover 50 between the cover 50 and theknob 60 and is slidably movable in a linear fashion between a forwardlocking position and a rearward unlocking position.

In the forward locking position, the front portion 92 of the lockingbutton 90 becomes seated underneath the flange 68 of the knob 60 andprevents the knob 60 from being pushed downwardly with respect to thecover. Since rotating the knob 60 clockwise causes the rectangular tabs59 on the inside of the cover 50 to ride up and over the ramped surfaces71 of the horizontal tabs 69 of the knob 60, the knob 60 has to traveldownwardly in order to be turned in the clockwise direction. A clickingsound may be heard as the rectangular tabs 59 are seated into therectangular gaps 73 as they ride up and over the ramped surfaces 71. Thefront portion 92 of the locking button 90 prevents this downwardmovement of the knob 60, preventing the rotation of the knob 60 in theclockwise direction.

Regarding the counterclockwise direction, the interlocking of therectangular tabs 59 within the rectangular gaps 73 normally prevents theknob 60 from turning backwards in a counterclockwise direction. For theknob 60 to be rotated in the counterclockwise direction, the knob 60needs to pressed downwardly with respect to the cover 50, wherein thetabs 59 located around the periphery of the flange 58 of the cover 50are freed from the rectangular gaps 73 defined between the horizontaltabs 69 of the knob 60, allowing the knob 60 to be turnedcounterclockwise and unwind the line 12, 22. However, as noted above,the front portion 92 of the locking button 90 prevents this downwardmovement of the knob 60.

When the locking button 90 is slid rearwardly to the unlocking position,the front portion 92 is removed from underneath the flange 68 of theknob 60, allowing the knob to be moved down with respect to the coverand rotated in either direction.

C. Tension Line and Barbed Suture

As discussed previously, the wound closure system 10 may include atension line 22 that is wound around the spool 20 of the tensioningapparatus 18 and that is coupled to the barbed suture line 12 that issutured to body tissue around the periphery of the wound 14. Such atension line 22 may be a nylon or polypropylene line, string, a cable, awire, or other similar item. The tension line 22 may be sufficientlyflexible and bendable to allow winding around the spool 20 within thetensioning apparatus 18. One embodiment of such a tension line 22 ismade from nylon and has a tensile strength of about six lbs to ten lbs.The tension line 22 may include a thread diameter of about 0.5 mm to 0.6mm.

As discussed before, although depicted as including a separatetensioning apparatus 18 in FIGS. 1-2, the wound closure system 10 mayinstead simply utilize an elastic line 22 that is connected to thebarbed suture line 12 or an elastic barbed suture line 12 itself toprovide the dynamic tension on the body tissue surrounding the wound 14.An elastic line or elastic suture line can also be used in combinationwith a separate tensioning apparatus such as the tensioning apparatus18.

With the use of a separate tension apparatus 18, the tension line 22and/or the barbed suture line 12 may be inelastic since the tensioningapparatus 18 provides the dynamic or continuous force needed for woundclosure.

Regarding the barbed suture 12, as noted above and illustrated in FIGS.1 and 2, the barbed suture line 12 includes a plurality of barbs 13distributed around the circumference of the suture line 12. Suturingneedles 16 may be provided at the ends of the barbed suture line 12 tofacilitate suturing to body tissue. As shown in FIG. 2, once the barbedsuture line 12 has been sutured around the wound area 14, the needles 16may be removed and the ends tied together to form a closed loop aroundthe wound area 14.

According to one embodiment of the suture line 12 of the wound closuresystem 10, the barbs 13 of the suture line 12 may be unidirectional suchthat all of the barbs 13 extend out at an acute angle along the samedirection with respect to the longitudinal axis of the suture line 12.It is also contemplated that the suture line 12 could be provided withtwo sections of barbs 13, wherein all the barbs 13 in the first sectionextend out at an acute angle in a first direction and all the barbs 13in the second section extend out at an acute angle in a second oppositedirection. Such suture lines 12 can be used, for example, when bodytissue on opposing sides of a wound 14 are sutured starting from thesame point going to the opposite end of the wound 14.

The barbs 13 of the barbed suture 12 may be flexible such that, whensuturing, they elastically flex inwardly toward the line surface tofacilitate passing through body tissue. When a barb 13 passes throughthe body tissue and comes out the other side of the body tissue, thebarb 13 may flex again outwardly from the suture line surface to providea catch and grabs the body tissue if the suture 12 is pulled in theopposite direction. In this manner, the barbed suture 12 can be suturedthrough the body tissue as in a conventional suture, however, preventingany back-up of the suture 12 once passed through body tissue.

The barbs 13 may be distributed individually in a 360° fashion aroundthe periphery of the suture line 12, with gaps provided between each ofthe barbs 13. According to other example embodiments of barbed sutures,instead of the barbs 13 being individually distributed around the sutureline, the barbs 13 may be grouped together, wherein a first group ofbarbs 13 may be located at a first radial location on the suture line12, a second group of barbs 13 may be located at a spaced second radiallocation on the suture line 12 (for example, on an opposite side of thesuture line 12 from the first group, etc.), and so forth.

As noted previously, the wound closure system 10 and the barbed sutureline 12 can be set up such that the tension force is applied in eitherdirection with respect to the barbs 13. If the tension is applied withthe direction of the barbs 13, the barbed suture 12 operates in asimilar manner to a conventional suture and slides through the bodytissue to pull the sides of the body tissue toward or over the openwound area 14. During this type of a suture set-up, the barbs 13 stillplay a role during the initial suturing of the body tissue by preventingback-up of the suture line 12. If the wound closure system 10 is usedsuch that tension is applied against the direction of the barbs 13, thetissue is stretched toward or over the open wound area 14 by thegrabbing action of the barbs 13.

One example embodiment of a barbed suture line 12 that is suitable foruse with the wound closure system 10 of the present disclosure ismanufactured by Covidien and marketed under the name “V-Loc™ 180Absorbable Wound Closure Device”. Another example embodiment of a barbedsuture line 12 that is suitable for use with the wound closure system 10of the present disclosure is available from Angiotech Pharmaceuticals,Inc. under the model name “Quill® SRS Self-Retaining System”.

As noted above, the barbed suture line 12 may be attached directly tothe tensioning apparatus 18 of the wound closure system 10 or may beattached thereto with a separate tension line 22 that is pre-woundaround the spool 20 of the tensioning apparatus 18. One example methodof attaching the barbed suture line 12 to a tension line 22 that isalready wound within the tensioning apparatus 18 is shown in FIGS.40-42. As shown in FIGS. 40-42, according to one embodiment, the barbedsuture line 12 may include a ball structure 24 crimped to the endthereof. The end that includes the crimped ball structure 24 could bethe end with the needle 16 or it could be the opposite end. The tensionline 22 that is pre-wound around the spool of the tensioning apparatusmay include a socket structure 26 crimped to the end of the tension line22. The socket structure 26 acts as a receiver for the ball structure 24in connecting the barbed suture line 12 to the tension line 22 in aquick and easy manner. Other methods of attachment may be used inattaching the barbed suture line 12 to a separate tension line 22wrapped around the spool 20 of the tensioning apparatus 18 of FIGS. 3-5.

Use of a barbed suture line 12 for the wound closure system 10 providesa number of advantages over prior art systems. Fever steps are needed ininitial set-up of the wound closure system 10. Use of body anchors 100and staples may be eliminated for the wound closure system 10. Thebarbed suture line 12 that is used in initially stretching the bodytissue can also be used for final closure of the wound 14 instead ofhaving to resuture the wound 14 after stretching. The physician cansimply pull the barbed suture line after the body tissue surrounding thewound has been stretched to close the wound. Due to the barbs, tying theends of the suture line is not necessary. Surgeons are generallyfamiliar with the suturing process so this type of a system providesless of a paradigm shift for surgeons in setting up the wound closuresystem 10.

D. General Use of Wound Closure System

The tensioning apparatus 18 of the wound closure system 10 of thepresent disclosure is used in a manner similar to that shown anddescribed in U.S. Pat. No. 7,455,681, the entire disclosure of which hasbeen incorporated herein by reference. For example, according to oneexample method, before applying dynamic or continuous tension to stretchthe tissue, the barbed suture line 12 may be sutured to body tissuesurrounding the wound area 14. The suturing may occur as shown in FIG.2, wherein the suture 12 is passed in and out of the body tissue aroundthe wound 14. As discussed previously, there are a number ofpossibilities on the types of barbed suture line(s) that could be usedand the direction of suturing. One or more barbed suture lines 12 can beused and attached directly to the spool 20 of the tensioning apparatus18. In other embodiments, the barbed suture lines 12 may be indirectlyattached to the tensioning apparatus 18 with the use of a pre-attachedtension line 22. As described, a ball/socket type of an attachmentarrangement can be used. In suturing the barbed suture 12, a singlesuture line, one end of which is attached to the tensioning apparatus18, can be sutured to the body tissue and the other end tied again tothe tensioning apparatus 18. According to other methods, two separatebarbed suture lines 12 that are attached to the tensioning apparatus 18can be sutured to body tissue starting from the same point going to theopposite end of the wound 14, wherein the ends of the lines 12 would betied to form a closed loop. As noted above, the direction of theapplication of the tension may be along the direction of the barbs 13 oropposite the direction of the barbs 13. Both methods are effective instretching the body tissue for wound closure. A single barbed sutureline 12 that has bidirectional barbs 13 can also be used. Such a barbedsuture line 12 might include suture needles 16 at both ends of the line12, as shown in FIG. 1, wherein the middle portion of the line 12 wherethe barbs 13 change direction can be attached to the spool 20 of thetensioning apparatus 18. According to one embodiment, the barbed sutureline 12 may extend around substantially the entire periphery of thewound 14 and application of tension to the suture line 12 draws andstretches the body tissue toward the wound 14 (see FIG. 2). According toanother embodiment, the suture line 12 can also be sutured to the bodytissue surrounding the wound 14 in a manner so as to extend across thewound 14, i.e., in a “shoe-lace” configuration in use of the woundclosure system 10 (see FIG. 2A). It should also be noted that althoughthe wound closure system 10 of the present disclosure has beenillustrated with a single tensioning apparatus 18, more than onetensioning apparatus 18 can be used. For example, two tensionapparatuses 18, one on each side of a generally elongate wound 14, canbe used. In one example variation of such a set-up, a barbed suture line12 from one tensioning apparatus 18 may be sutured in one direction anda barbed suture line 12 from the other tensioning apparatus 18 may besutured in the opposite direction, wherein tension applied by the twotensioning apparatuses 18 would cause the barbs 13 to grab the tissueand pull both sides of the tissue inwardly toward the wound 14.

In certain embodiments, a wound closure system having two barbed suturelines, wherein one suture line would go into the deepdermis/subcutaneous layer and the second suture line would go into thedermal/subcuticular layer to provide a two-layer closure, could beimplemented.

It should be noted that the above described set-up arrangements aresimply examples and other arrangements can certainly be used in settingup the wound closure system 10 of the present disclosure.

In assembling the tensioning apparatus 18, according to one specificexample embodiment, after one or two barbed suture line(s) 12 has beenattached to the spool 20 either directly or indirectly through theopenings 5 and 7 and wound around the spool 20, the tensioning apparatus18 may be assembled with the spool 20 fitting into the base 40. Afterwinding of the tension line 22 or the barbed suture line 12, the biasingmember 30 is placed on top of the spool 20, the knob 60 is placed on topof the biasing member 30 after the dowel pin 80 and the linear spring 70are placed within the well 19 of the spool 20. The cover 50 is thenmounted on top of the base 40 trapping the knob 60 thereinbetween thebase 40 and the cover 50 and the line(s) 12, 22 guided out of the snoutportion 52 of the cover 50. After assembly, the barbed suture lines 12that are attached to the tensioning apparatus 18 can be sutured to bodytissue starting from the same point going to the opposite end of thewound 14, wherein the ends of the lines 12 can be tied to form a closedloop. There should be enough line 12 let-out initially to perform thesuturing operation.

After the barbed suture line(s) 12 is sutured to body tissue and theloop closed, the knob 60 of the tensioning apparatus 18 may be turnedclockwise to wind the biasing member 30 located therewithin and startpulling in the barbed suture line 12.

Rotating the knob 60 clockwise causes the rectangular tabs 59 on theinside of the cover 50 to ride up and over the ramped surfaces 71 of thehorizontal tabs 69 of the knob 60. The linear spring 70 protruding outof the spool 20 is used to exert an upward force on the knob 60 to keepthe horizontal tabs 69 of the knob 60 pressed against the flange 58 ofthe cover 50. A clicking sound may be heard as the rectangular tabs 59are seated into the rectangular gaps 73 as they ride up and over theramped surfaces 71. The interlocking of the rectangular tabs 59 withinthe rectangular gaps 73 prevents the knob 60 from turning backwards in acounterclockwise direction.

When the knob 60 is turned clockwise, the biasing member 30 is loadedbecause the outer tab portion 33 of the coiled band 31 fits into one ofthe vertical indents 65 causing the biasing member 30 to turn with theknob 60. When the coiled band 31 is initially in an unwound orientation,the large diameter of the band 31 creates a tight fit with the interiorsurface 64 of the knob 60 creating a substantial amount of friction withthe interior surface 64 of the knob 60. In this manner, the outer tabportion 33 is kept pressed against the inner surface 64 of the knob 90,within one of the vertical indents 65. As the biasing member 30 iswound, it becomes smaller and eventually obtains a diameter small enoughthat the outer tab 33 no longer exerts enough friction force against theinterior surface 64 of the knob 60. At this point, further winding ofthe knob 60 causes the outer tab portion 33 to slip out of the verticalindents 65. This slipping makes an audible sound and gives an indicationthat the biasing member 30 is fully wound.

Since the spool 20 is connected to the biasing member 30, turning of theknob 60 also causes turning of the spool 20, tightening the barbedsuture line 12 around the wound area 14. The biasing member 30 is woundto such extent that it applies a dynamic force on the barbed suture line12 pulling the body tissue toward the wound 14. The design of the snout52 of the cover 50 makes it possible to concentrate all the pullingforce into one area. The snout 52 also inhibits any pulling on thetensioning apparatus 18 because the tip of the snout 52 aligns thetensioning apparatus 18 with the loop of the barbed suture line 12around the periphery of the wound 14 diverting all the tension forces toa transverse direction along the loop instead of in the direction of thesnout 52 itself. As the tissue is stretched toward the wound 14, thewound-up biasing member 30 and hence the spool 20 keeps the barbedsuture line 12 taut. It should be noted that if the tension is beingapplied in the direction of the barbs 13, the biasing member 30 causesthe barbed suture line 12 to slide through the body tissue as the bodytissue is stretched. If the tension is being applied opposite to thedirection of the barbs 13, the biasing member 30 causes the barbs 13 tocatch the body tissue and stretch the body tissue by the grabbingaction.

Occasionally it may be necessary to release the barbed suture line 12 toresuture or reposition it for adjustments or to remove the tensioningapparatus 18. Pushing down on the knob 60 causes the linear spring 70(see FIGS. 4 and 5) to compress and the rectangular tabs 59 on theinside of the cover 50 to disengage from the rectangular gaps 73 definedaround the knob 60. This causes the knob 60 to be able to be turnedbackwards in the counterclockwise direction and the barbed suture line12 to come out.

During use, the locking button 90 may be used to lock the knob 60 withrespect to the rest of the tensioning apparatus 18 to prevent anyunwanted rotation of the knob 60.

The above specification provides examples of how certain inventiveaspects may be put into practice. It will be appreciated that theinventive aspects can be practiced in other ways than those specificallyshown and described herein without departing from the spirit and scopeof the inventive aspects.

1. A wound closure system comprising: a suture line adapted to besutured through body tissue adjacent an open wound, the suture lineadapted to be sutured so as to pass into the body tissue at an entrypoint and exit at an exit point, the suture line including a pluralityof barbs extending outwardly at an acute angle with respect to a surfaceof the suture line; and a biasing member that is adapted to apply acontinuous pulling force on the suture line for stretching the bodytissue toward the open wound, wherein the biasing member is configuredto take up any slack of the suture line during stretching of the bodytissue and keep the suture line taut.
 2. A wound closure systemaccording to claim 1, wherein the suture line includes the biasingmember.
 3. A wound closure system according to claim 1, wherein thebiasing member includes a spring.
 4. A wound closure system according toclaim 3, further comprising a housing that houses the spring, thehousing including a spool rotatably coupled to the housing, the spoolcoupled to the spring and adapted for winding the spring for theapplication of the continuous pulling force on the suture line.
 5. Awound closure system according to claim 4, wherein the housing and thespring include intermating structures adapted for winding the spring,wherein the intermating structures are adapted to slip with respect toeach other when the spring has been fully wound to provide an indicationthat the spring is fully wound.
 6. A wound closure system according toclaim 5, wherein the intermating structures include radially arrangedvertical indents formed within the housing and a radially outwardlyprojecting tab of the spring.
 7. A wound closure system according toclaim 4, wherein the housing includes a second line that is wound aroundthe spool, the second line detachably coupled to the suture line for theapplication of the continuous pulling force on the suture line.
 8. Awound closure system according to claim 7, wherein the suture line isdetachably attached to the second line using a ball/socket joint.
 9. Awound closure system according to claim 4, wherein the housing includesa button that can be pushed along a longitudinal direction of the spoolto release the continuous pulling force.
 10. A method of reducing thesize of an open wound by pulling body tissue adjacent the open woundtoward or over the open wound, the method comprising: suturing a sutureline through the body tissue adjacent the open wound so as to pass intothe body tissue at an entry point and exit at an exit point, the sutureline including a plurality of barbs extending outwardly at an acuteangle with respect to a surface of the suture line; and providing abiasing member that continuously applies a pulling force on the sutureline to stretch the body tissue toward or over the open wound, whereinthe continuous pulling force is automatically applied by the biasingmember during stretching of the body tissue.
 11. A method according toclaim 10, further comprising suturing the suture line through bodytissue surrounding substantially the entire periphery of the open wound.12. A method according to claim 11, wherein no portion of the biasingmember is located within the periphery of the open wound.
 13. A methodaccording to claim 10, further comprising suturing the line through thebody tissue in a shoe-lace configuration wherein at least a portion ofthe suture line crosses the open wound at least twice.
 14. A methodaccording to claim 13, wherein no portion of the biasing member islocated within the periphery of the open wound.
 15. A method accordingto claim 10, wherein the biasing member is separate from the sutureline.
 16. A method according to claim 15, wherein the biasing member isa spring.
 17. A method according to claim 16, further comprisingproviding a housing that houses the spring, the housing including aspool rotatably coupled to the housing, the spool coupled to the springand adapted for winding the spring for the application of the continuouspulling force on the suture line.
 18. A method according to claim 17,wherein the housing and the spring include intermating structuresadapted for winding the spring, wherein the intermating structures areadapted to slip with respect to each other when the spring has beenfully wound to provide an indication that the spring is fully wound. 19.A method according to claim 10, further comprising providing thecontinuous pulling force on the suture line along the direction of thebarbs such that the suture line slides through the body tissue with thebarbs passing through the body tissue.
 20. A method according to claim10, further comprising providing the continuous pulling force on thesuture line against the direction of the barbs such that the barbs catchthe body tissue and stretch the body tissue toward or over the openwound.
 21. A wound closure system according to claim 1, wherein thebarbs are configured to be flexible so as to flex toward the surface ofthe suture line when the barbs enter the body tissue and flex outwardlyaway from the surface of the suture line when the barbs exit the bodytissue.
 22. A method according to claim 10, wherein the barbs areconfigured to be flexible so as to flex toward the surface of the sutureline when the barbs enter the body tissue and flex outwardly away fromthe surface of the suture line when the barbs exit the body tissue.